Molded Insole, Footwear Item, And Manufacturing Method

ABSTRACT

A molded insole includes a base, an internal lateral arch that is provided to accommodate the arch of the foot and that is raised relative to the base, and at least one hard region that is integrated into the base, having a hardness equal to or greater than that of the base. The base and the internal lateral arch of the insole constitute a single, mono-material part.

TECHNICAL AREA

The present invention relates to a molded insole, designed to fightagainst venous stasis induced by venous insufficiency in a patient, andthus improve venous return.

The insole is specifically adapted to the morphology of a patient'sfoot, in particular a senior patient, suffering from venousinsufficiency. It is designed for the uniform improvement of venousreturn, regardless of the patient's plantar morphology. It can beinserted or directly integrated into any type of footwear, such asstockings, tights, socks or shoes including flip-flops and sandals.

STATE OF THE ART

Venous insufficiency is characterized by dilation of the veins ordeterioration of the anti-reflux valves. This pathology is common inelderly patients. A reflux sets in and causes an increase in bloodpressure in the veins. The slowing of the velocity of blood circulationthus leads to the first signs of the disease. The blood that stagnatesin a vein can then cause a breakdown of the vein wall, causingdeformation and the appearance of varicose veins. Among the risk factorslinked to this pathology can be cited, for example, heredity, gender,age, obesity, position at work, pregnancy, menopause, and plantardysmorphisms. In a known way, venous return can be improved by wearinginsoles with variations in density.

Document EP 0 971 606 discloses an insole comprising severalcushion-shaped layers configured to improve venous return. These layersare each separated into several plate-shaped fields juxtaposed in thetransverse direction with respect to the insole axis. The layer forminga bump at the internal lateral arch sits on the base of the insole andis optional.

Document WO 2011/135278 discloses a plastic insole having zones forreducing pressure, which include orifices having less rigidity. Thisinsole also increases blood flow and circulation in the foot.

Document WO 2011/017174 Al discloses an insole for improving comfort, inparticular when running and walking. The insole comprises three portionsattached to a central base, namely an external lateral arch, an internallateral arch and a portion opposite the heel. The portion opposite theheel has a greater hardness than the base and the external lateral arch,which, themselves, have a greater hardness than the internal lateralarch. Each of the elements is manufactured separately then associatedwith the central base by conventional gluing techniques, for example.

DISCLOSURE OF THE INVENTION

The object of the invention is to propose a new insole to fight againstvenous stasis induced by venous insufficiency.

To this end, the invention relates to a molded insole, comprising abase, an internal lateral arch that is provided to accommodate the archof the foot and that is raised relative to the base, and at least onehard region that is integrated into the base, having a hardness equal toor greater than that of the base. This insole is characterized in thatthe base and the internal lateral arch constitute a single,mono-material part. The base extends, in practice, over the entiresurface of the foot with the exception of the portion occupied by theinternal lateral arch.

In addition, and according to another advantageous characteristic, thebase is configured so that its upper surface does not undergodeformations in contact with the hard regions at the time of itsintegration after molding. In other words, the upper surface of theinsole is smooth in the sense that it does not have any bumps next tothe hard regions.

In practice, and as will be explained later, the hard regions areintegrated into hollow chambers formed in the thickness of the base andopening onto the underside of said base. In other words, the lateralarch does not contain an integrated hard region within the meaning ofthe invention.

Thus, the insole is simpler and more economical to manufacture, due tothe use of a single material to produce the base and the internallateral arch of the insole, and the fact that the base and the internallateral arch constitute a single part, compared to bi-material insolesand/or insoles integrating an added arch, as is the case, for example,in document WO 2011/017174 A1. In addition, the insole according to theinvention is designed to adapt easily to each type of foot, flat, hollowor physiological.

The internal lateral arch is designed to accommodate the arch of thepatient's foot. This configuration promotes venous return by compressingthe plantar venous reservoir when walking, thanks, in particular, to theraised position of the internal lateral arch, formed projecting from thebase.

Preferably, the internal lateral arch has a volume adapted to the volumeof the patient's arch, in particular in the case of dysmorphia.

According to the invention, the thickness of the internal lateral archcorresponds to the thickness of mono-material constituting said arch. Inpractice, this thickness decreases from the center of the insole towardsthe inside of the insole. In other words, it decreases substantiallyfrom the center of the insole towards its periphery, on the inside ofthe foot.

The volume of the arch of the foot corresponds to the volume between theupper side of the insole and the plane extending the lower surface ofthe base under the internal lateral arch.

The correct positioning of the volume of the internal lateral arch onthe insole is guaranteed by matching, from the rearmost point of theinsole, the geographical location of an anatomical reference point takenon the arch of the foot with respect to the rear of the foot. Thisanatomical reference point is, in practice, the highest elevation pointof the arch of the foot, i.e., corresponding to the maximum hollowformed in the arch of the foot between the underside of the base and theunderside of the arch.

The internal lateral arch is defined by a virtual line corresponding tothe maximum thickness of the insole for each of the vertical crosssections of the insole in the direction of the width of the insole.

The thickness of the insole increases from the external side of theinsole towards the internal side of the arch to reach its maximumthickness along this virtual line. From this maximum thickness, thethickness of the insole decreases again from the external side of theinsole towards the internal side of the arch.

The thickness of the insole increases along this virtual line from its 2extremities to reach a maximum value near its center. In other words,the insole reaches a maximum thickness approximately halfway between the2 ends of the virtual line.

Preferably, the volume and position of the internal lateral arch aredetermined according to three parameters: the gender of the patient; thepatient's shoe size; and the morphology of the patient's foot.

On this basis, the morphology parameter of the patient's foot definesthree possibilities: flat, hollow or physiological foot.

The insoles differ from each other for these 3 types of morphology bytheir maximum thickness at approximately halfway between the 2 ends ofthe virtual line defining the internal lateral arch.

As mentioned before, this thickness subsequently decreases:

-   -   towards the inside of the insole depending on the volume of the        arch of the foot, to reach, in practice, a value of less than 2        mm, for example of the order of 1.5±0.3 mm,    -   towards the outside of the insole to reach, in practice, a value        of at least 3 mm, preferably around 3.5±0.3 mm.

According to the invention, the maximum thickness of the insole is5.6±0.2 mm for a flat foot, 8.4±0.4 mm for a hollow foot and 8.8±0.2 mmfor a physiological foot.

Preferably, the internal lateral arch has a curved lower surface forminga hollow with respect to the lower plane of the base, and a curved uppersurface forming a projection with respect to the upper plane of thebase.

Similarly, and in practice, the lower surface of the internal lateralarch has a greater slope than the upper surface of the arch.

In the embodiment where the hardness of the hard regions is greater thanthat of the base, the base may have a hardness between 22 and 50 on theShore A scale depending on its thickness. The hardness of elastomers maybe measured according to ISO 868/DIN 53505/ASTM 2240 standards. The basemay have a density between 120 and 465 kg/m³ depending on its thickness.

In practice, and always in this embodiment, the hard regions may have ahardness between 53 and 58 on the Shore A scale, preferably 55 on theShore A scale. The hard regions may have a density between 494 and 690kg/m³, preferably between 570 and 610 kg/m³, for example 590 kg/m³.

For example, the hard regions may be made of 95% polyurethane and 5%carbon foam, while the part formed by the base and the internal lateralarch may be made of 100% polyurethane foam.

More generally, the insole may be made of all types of polymers ornatural materials, pure or as a mixture, containing or not containingfillers or additives providing additional properties of the anti-odortype.

The insole may include a top layer covering the base and the internallateral arch. This upper layer constitutes an accommodating surface forthe foot resting on the insole, as well as a protective element. It thusmakes it possible to avoid direct contact between the insole and thearch of the patient's foot and to improve comfort and hygiene whenwearing the insole. This layer is made of flexible material, for examplemade from a composition of 90% microfiber polyamide and 10%polyurethane.

The applicant found that particularly advantageous results were obtainedin terms of venous return when the hardness of the insole, in the partsof the base without a hard region, measured on the upper side of theinsole and over its entire thickness, was between 30 and 56 on the ShoreA scale depending on the thickness of the insole, and that the hardnessof the insole, in the parts of the base incorporating the hard regions,measured under the same conditions, was between 65 and 77 on the Shore Ascale depending on the thickness of the insole.

Thus, the invention also relates to a molded insole, comprising a baseand an internal lateral arch provided to accommodate the arch of thefoot, raised relative to the base, the base integrating hard regions.This insole is characterized in that the base and the internal lateralarch of the insole constitute a single mono-material part,advantageously covered with an upper layer over its entire surface, andin that:

-   -   the hardness of the insole, in the parts of the base without        hard regions, measured on the upper side and over its entire        thickness, is between 30 and 56 on the Shore A scale depending        on the thickness,    -   the hardness of the insole, in the parts of the base        incorporating hard regions, measured on the upper side and over        its entire thickness, is between 65 and 77 on the Shore A scale        depending on the thickness.

The hardness of elastomers may be measured according to ISO 868/DIN53505/ASTM 2240 standards.

According to the invention, the hardness may vary from one point toanother on the surface of the insole within the ranges mentioned above.

In the present application, the limits of each density or hardness valuerange are included in the range.

According to the invention, the hard regions are formed by insertsintegrated into the base. In practice, the base has chambers in whichthe hard regions are inserted. Thus, the insole has a smooth surface,i.e., an upper surface containing no localized extra thickness next tothe hard regions. This makes it possible not to modify theproprioception sensations of the foot.

Preferably, the hard regions are laid out in the open air under thebase. In other words, the hard regions are not covered by an additionallayer of material. This reduces the time and cost of manufacturing theinsole. Similarly, and still according to the invention, the hardregions are flush with the lower surface of the base and are, therefore,not projecting from the lower surface of the base.

As mentioned above, the results on venous return are even moreconvincing in the hardness ranges mentioned above and measured on theupper side of the insole.

A person skilled in the art will be able to determine the nature of thematerials of the base and the hard regions to be implemented, as well asthe compressive force to be applied to the base at the time of molding,in order to obtain the hardness within the ranges described.

The present invention also relates to a footwear item, for examplestockings, tights, socks or shoes including flip flops and sandals,comprising an insole as defined above.

The insole may constitute a distinct element of the footwear item, i.e.,the insole may be placed at the bottom of the footwear item to wear it.Alternatively, the insole may be directly integrated into the footwearitem. This allows relatively varied uses of the insole.

The insole may be adapted for a flat, hollow or physiological foot.Within the meaning of the invention:

-   -   a flat foot corresponds to a CSI strictly greater than 0.4;    -   a hollow foot corresponds to a CSI strictly less than 0.3;    -   a physiological foot corresponds to a CSI between 0.3 and 0.4.

The CSI is the Chippaux Smirak Index, representing the ratio between theminimum width of the footprint at the arch of the foot (DC length) andthe maximum width of the footprint at the metatarsals (AB length), asshown in FIG. 10 .

The index is defined by the formula: CSI=(DC)/(AB)×100.

The invention also relates to a manufacturing method of an insole asmentioned above. The process includes the following steps:

-   -   a) a step of forming at least one hard region having a hardness        equal to or greater than that of the base;    -   b) a step of cutting, from a mono-material strip, with or        without an upper layer laminated on its surface, a preform to        the dimensions of the mold corresponding to the insole;    -   c) a step of molding the preform, as a part comprising the base        and the internal lateral arch formed projecting from the base,        to the desired size of the insole;    -   d) a step of assembling the part comprising the base and the        lateral arch once removed from the mold; and hard regions; and    -   e) a finishing step to obtain the insole.

Advantageously, step c) of molding the preform is carried out bycompressing a mono-material part of constant thickness, hardness anddensity in a mold, the mold being in shapes intended to configure thebase so that its upper surface does not undergo deformations in contactwith hard regions.

According to a particular embodiment, step c) may first comprise a stepof laminating a strip corresponding to the upper layer over the entiresurface of the mono-material strip.

According to a particular embodiment, the finishing step e) may consistin cutting out the outline of the pre-insole in order to obtain theinsole in its final state.

Alternatively, the insole may be manufactured by other techniques, forexample by 3D printing.

The insole may receive design elements by screen printing, pad printing,transfer, or any other technique (for adding a logo, marking areas,various style effects).

The insoles may be mass-produced, including different sizes anddifferent morphologies (flat foot, hollow foot or physiological foot),depending on the gender of the patient. Alternatively, the insoles maybe custom-made, depending on the morphology of the patient's foot.

DESCRIPTION OF THE FIGURES

The invention will be better understood on reading the followingdescription, given solely by way of non-limiting example and made withreference to the appended drawings in which:

FIG. 1 is a schematic top view of a molded insole according to theinvention according to the arrow I of FIG. 3 .

FIG. 2 is a schematic view from below of the insole of FIG. 1 accordingto the arrow II of FIG. 3 .

FIG. 3 is a lateral view of the insole of FIGS. 1 and 2 from theperiphery of the internal lateral arch, on the internal side of thefoot.

FIG. 4 is a front view of the insole, according to the arrow IV in FIG.1 .

FIG. 5 is a rear view of the insole, according to the arrow V in FIG. 1.

FIGS. 6, 7 and 8 are sections of the insole seen from below in FIG. 2 ,along the axes VI, VII and VIII respectively.

FIG. 9 is a perspective view from the front and top of a pair of insolesaccording to the invention, with the insole on the right in real view,and the insole on the left in conceptual view, with elevation linesshown on the arch, and hard regions shown in dotted lines on the base.

FIG. 10 is a schematic representation of the underside of a right foot,illustrating the Chippaux Smirak Index (CSI).

DETAILED DESCRIPTION

FIGS. 1 to 10 show a molded insole (1) designed to fight against venousstasis induced by venous insufficiency in a patient.

The insole (1) comprises a base (10), an internal lateral arch (20)raised relative to the base (10), four hard regions (30 (31, 32, 33,34)) having a hardness greater than that of the base (10), and a toplayer (40).

According to the invention, the base (10) and the internal lateral arch(20) of the insole constitute a single, mono-material part (2). Thus,the insole (1) is simple and economical to manufacture, due to the useof a single material to make the base (10) and the internal lateral arch(20) of the insole (1).

The base (10) is substantially planar.

The internal lateral arch (20) constitutes a portion of the insole (1),provided to accommodate the arch of the patient's foot. Thisconfiguration promotes venous return, thanks, in particular, to theraised position of the internal lateral arch (20), formed projectingfrom the upper side of the base (10). The internal lateral arch (20) hasa curved shape so as to match the shape of the arch of the patient'sfoot.

As shown in FIG. 1 in particular, the internal lateral arch (20) isdefined by a virtual line connecting the periphery of the insole, on theinternal side of the foot, in front of the heel to the periphery of theinsole, on the internal side of the foot, near the base of themetatarsus in the longitudinal direction, this virtual line passing nearthe center of the insole in the transverse direction.

According to the invention, the insole reaches a maximum thicknessapproximately halfway between the 2 ends of the virtual line definingthe lateral arch designated “MAX” in FIG. 1 .

The thickness of the insole increases from the external side of theinsole towards the internal side of the arch to reach its maximumthickness along the virtual line. From this maximum thickness, thethickness of the insole decreases again.

The internal lateral arch is defined by this virtual line correspondingto the maximum thickness of the insole for each of the vertical crosssections of the insole, in the direction of the width of the insole.These values are designated MAX1, MAX1, MAX2, MAX2′ etc. and graduallyincrease to the MAX value.

The arch (20) has a curved lower surface (21) forming a hollow withrespect to the lower plane (P11) of the base (10). The arch (20) has acurved top surface (22) projecting from the top plane (P12) of the base(10). The lower surface (21) has a steeper slope than the upper surface(22) of the arch (20). This allows the insole to match the morphology ofthe arch of the foot.

In practice, the plantar venous reservoir is positioned in the lateralplantar veins located deep at the arch of the foot.

By following the shape of the arch of the foot, the internal lateralarch (20) acts as a “pump” for the deep activation of the lateralplantar veins.

This action is particularly useful in case of dysmorphism of thepatient, characterized by a deformation of the arch of the foot leadingto poor functioning of the plantar pump linked to the anatomicalmodifications. The insole (1) then allows to correct this problem.

The hard regions (30) are spaced apart along a longitudinal direction ofthe insole (1). These hard regions (30) correspond to the foot supportpoints: sole of the foot (central zone of the foot), metatarsus(forefoot), heel and tarsus (rearfoot). The specific location of thehard regions (30) allows to distribute in a homogeneous manner theweight of the body while in a standing position from these pointssubject to strong stresses over the entire surface located under thefoot. Moreover, the hard regions (30) constitute a reinforced protectionof these sensitive points.

The hard regions (30) are auxiliary activators for improving venousreturn. Due to their location, and their hardness equal to or greaterthan that of the base (10), the hard regions (30) act at the surface ofthe soles of the feet to create a “2nd pump” effect, as a complement tothe “1st pump” effect created by the internal lateral arch (20) actingin depth to activate the lateral plantar veins.

This effect is reinforced by the fact that the base is configured sothat its upper surface does not undergo deformations in contact with thehard regions at the time of manufacture of the insole, as will be seenlater. Therefore, the surface of the insole is smooth.

More particularly, the hard regions (30) may be formed by inserts (31,32, 33, 34) integrated into chambers provided in the base (10). Thisintegration may be done, for example, by laminating the inserts (31-34)on the base (10).

The inserts (31-34) act as reinforcements, arranged on the underside ofthe insole (1) and corresponding to the bearing points of the patient'sfoot on the insole.

The inserts (31-34) have different geometric shapes, corresponding tothe surface of the patient's bearing points:

-   -   the insert (31) is located at the forefoot, below the phalanges,    -   the insert (32) is located in the central zone of the foot,    -   the insert (33) is located in a zone close to the heel, between        the central zone and the heel,    -   the insert (34) is located under the heel.

As shown in FIGS. 6 and 8 , in particular, the base (10) comprisescavities or chambers for accommodating the inserts (31-34). Thethickness of the base (10) is reduced in these cavities. This thicknessis such that the upper surface of the base does not undergo deformationsin contact with hard regions during manufacture, which contributes tothe improvement of venous return. In practice, the hard regions (30) areflush with the lower surface of the base (10). This makes it possible tohave contact at all points between the underside of the insole and theshoe.

The internal lateral arch (20) of each insole (1) is designed accordingto the gender, size and morphology of the patient's foot (flat foot,hollow foot or physiological foot). Advantageously, the internal lateralarch (20) is designed with a volume specifically adapted to the volumeof the patient's arch of the foot, in particular in the event ofdysmorphia. This volume may be determined by acquisition by 3D scanner.The volume of the internal lateral arch (20) is then the 3D shape of thearch of the foot. The correct positioning of the volume of the internallateral arch (20) on the insole (1) is guaranteed by matching, from therearmost point of the insole (1), the geographical location of ananatomical reference point taken on the arch of the foot in relation tothe rear of the foot. Preferably, this anatomical reference point is thepoint of highest altitude of the arch of the foot, i.e., correspondingto the maximum hollow formed in the arch of the foot. FIGS. 6, 7 and 8show cross sections of the insole at different locations:

-   -   The cross section VI is made close to the heel,    -   The cross section VII is made in the rear middle part of the        insole,    -   The cross section VIII is made in the front middle part of the        insole.

As the cross section VI shows, the insole (1) has a constant thicknessat the heel, in practice of the order of 3.5 mm, then graduallyincreases near the virtual line, appearing in a solid line, then reachesthe virtual line at the MAX1 value greater than 3.5 mm. The thickness ofthe lateral arch then decreases towards the inside of the insole.

The cross section VII corresponds to the section of the insole with themaximum thickness. It is designated MAX.

The cross section VIII corresponds to a section of the insole with aconstant thickness across its width, which means that this section doesnot contain the internal lateral arch. The thickness of the insole isconstant here, in practice approximately 3.5 mm over its entire width.

As already stated, the insoles are different depending on the morphologyof the patient's foot. What changes from one insole to another isessentially the MAX maximum thickness that said insole may reach, inpractice 5.6±0.2 mm for a flat foot, 8.4±0.4 mm for a hollow foot and8.8±0.2 mm for a physiological foot.

The insole (1) preferably comprises an upper layer (40), covering themono-material part (2), to improve the comfort and hygiene of the insole(1). The upper layer (40) constitutes an accommodating surface for thefoot resting on the insole (1). To mass-produce a range of insoles (1),one mold is available per gender and per size (for example, 36 to 41 forwomen; 39 to 45 for men), and per type of arch (flat, hollow orphysiological).

Clinical trials were carried out to test the insole (1) according to theinvention as to its effectiveness on improving venous return.

The insoles (1) tested comprise a base (10) of 100% polyurethane foam,with a hardness of 22-50 on the Shore A scale depending on itsthickness, as well as hard regions (30) composed of a foam consisting of95% polyurethane and 5% carbon, with a hardness of 56 on the Shore Ascale.

In the parts free of hard regions measured on the upper side and overits entire thickness, the insoles have a hardness of between 30 and 56on the Shore A scale depending on the thickness.

In the parts incorporating hard regions measured on the upper side andover its entire thickness, the base of the insoles has a hardness ofbetween 65 and 77 on the Shore A scale depending on the thickness.

The hardness of the elastomers was measured according to ISO 868/DIN53505/ASTM 2240 standards.

On the upper side, in contact with the foot, the insole is covered withan upper layer (40) composed of 90% polyamide microfiber and 10%polyurethane.

First, the effect of wearing a pair of molded insoles (1) on thevelocity of venous return was compared to the effect obtained when notwearing these insoles (1). Also, the effect of wearing a pair of insoles(1) on postural stability in a standing position (eyes closed and eyesopen) was compared to the effect obtained when not wearing theseinsoles.

A population of 75 subjects was divided into 3 groups of 25, dependingon the type of foot: hollow, flat or physiological).

The tests were carried out to study four criteria:

-   -   1—Evaluation and comparison of the evolution of the maximum        velocity of the venous flow at the popliteal vein (called PV:        Peak Velocity) between morning and evening, after wearing        insoles (1) for one day and one day without wearing insoles (1).    -   2—Evaluation and comparison of the evolution of the maximum        velocity of the venous flow at the popliteal vein, averaged over        a window of time (called TAPV: Time Average Peak Velocity)        between morning and evening, after wearing insoles (1) for one        day and one day without wearing insoles (1).    -   3—Evaluation and comparison of the evolution of the average        velocity of the venous flow over the entire section of the        popliteal vein, averaged over a time window (called TAMV: Time        Average Mean Velocity) between morning and evening, after        wearing insoles (1) for one day and one day without wearing        insoles (1).    -   4—Evaluation and comparison of the evolution of postural        stability between morning and evening, in a standing position        (eyes closed and eyes open) after wearing insoles (1) for one        day and one day without wearing insoles (1), by analyzing:        -   the length traveled by the center of pressure (COP) over 30            seconds of recording,        -   the area of the ellipse in mm².

For the first three criteria presented above, the study shows thatwearing an insole (1) leads to a clear improvement in venous return withwearing an insole (1) between morning and evening, and a clearimprovement of venous return at fixed time (e.g., evening).

In the tables below, the results obtained are expressed in percentagesand show an average improvement of 49.9% for the 75 subjects, brokendown into 55.95% for the flat foot group, 44.96% for the hollow footgroup; 48.76% for the physiological foot group.

Table 1 below corresponds to the control test (without insole). Subjects1 to 25 have flat feet, subjects 26 to 50 have hollow feet, and subjects51 to 75 have physiological feet.

TABLE 1 CONTROL (WITHOUT INSOLE) Morning Evening Evolution EvolutionEvolution Type of Subject PV TAPV TAMV PV TAPV TAMV of PV of TAPV ofTAMV feet No. (cm/s) (cm/s) (cm/s) (cm/s) (cm/s) (cm/s) (%) (%) (%) FLAT1 3.95 3.42 1.15 4.05 3.28 1.14 2.56% −4.15% −1.04% FEET 2 17.79 10.563.65 16.42 12.31 6.25 −7.70% 16.57% 71.03% 3 10.71 5.27 1.67 9.65 4.751.51 −9.90% −9.86% −9.52% 4 5.41 4.35 2.05 5.43 4.32 1.98 0.33% −0.76%−3.46% 5 3.87 2.74 0.88 3.86 2.74 0.92 −0.08% 0.07% 4.27% 6 15.71 12.574.88 15.61 9.77 4.08 −0.64% −22.27% −16.34% 7 7.74 5.63 2.29 7.67 5.401.97 −0.87% −4.14% −13.85% 8 3.84 3.04 1.04 3.82 2.98 1.05 −0.36% −1.81%0.19% 9 5.75 4.83 2.23 7.62 6.22 2.59 32.52% 28.94% 16.48% 10 10.32 8.341.59 10.47 8.64 1.60 1.43% 3.63% 0.38% 11 18.09 15.09 6.34 18.06 15.176.30 −0.17% 0.53% −0.63% 12 13.46 10.63 3.10 11.33 9.49 2.91 −15.82%−10.67% −6.19% 13 5.29 4.51 1.70 4.96 4.07 1.63 −6.26% −9.74% −3.60% 1410.28 8.31 3.29 10.47 8.38 2.71 2.56% −4.15% −1.04% 15 17.60 12.45 5.7119.56 14.10 6.14 11.14% 13.25% 7.55% 16 12.20 8.95 3.74 13.49 10.57 4.0110.57% 18.04% 7.25% 17 19.37 16.29 6.70 16.66 12.19 4.78 −13.99% −25.17%−28.71% 18 9.65 7.56 1.93 8.05 5.49 1.56 −16.57% −27.33% −19.35% 19 5.104.13 1.47 7.16 5.75 1.45 40.40% 39.37% −1.30% 20 26.44 17.73 8.33 23.4716.20 7.95 −11.23% −8.63% −4.64% 21 14.23 12.10 4.49 14.32 11.95 4.120.63% −1.24% −8.05% 22 11.95 10.25 4.36 11.85 9.33 2.99 −0.84% −8.94%−31.54% 23 6.70 5.07 1.92 12.48 10.64 3.57 86.35% 109.74% 85.71% 2411.17 8.01 1.87 11.21 8.03 2.68 0.36% 0.25% 43.57% 25 16.59 10.00 4.9720.69 12.00 5.92 24.71% 20.07% 19.04% Average 11.33 8.47 3.25 11.53 8.553.27 5.13% 4.66% 3.59%

26 7.15 6.03 2.04 6.11 5.00 1.79 −14.58% −17.10% −12.40% 27 5.30 3.781.84 5.24 4.02 1.86 −1.09% 6.36% 0.65% 28 3.32 2.63 1.12 3.61 3.00 1.238.55% 14.10% 9.26% 29 10.59 7.82 3.45 8.17 6.36 2.98 −22.89% −18.67%−13.62% 30 5.67 4.82 2.42 5.77 4.87 2.42 1.75% 1.00% 0.00% 31 4.94 4.011.40 4.97 3.99 1.40 0.59% −0.37% −0.21% 32 5.61 4.64 1.78 5.62 4.66 1.770.23% 0.50% −0.56% 33 9.81 8.40 2.69 10.00 8.90 2.66 1.94% 5.92% −0.89%34 13.48 11.99 4.77 12.19 10.93 4.38 −9.57% −8.83% −8.24% 35 4.64 3.461.21 4.59 3.34 1.19 −1.06% −3.38% −1.32% 36 3.84 2.62 0.95 3.84 2.630.95 0.03% 0.42% −0.21% 37 5.68 3.99 1.52 6.57 4.43 1.61 15.68% 11.11%6.19% 38 7.98 5.58 1.74 8.00 5.61 1.74 0.16% 0.43% 0.06% 39 9.94 7.892.71 8.16 6.44 2.24 −17.89% −18.38% −17.62% 40 6.05 4.75 1.59 6.25 5.011.66 3.44% 5.41% 4.59% 41 8.75 7.45 1.94 8.91 7.63 2.12 1.82% 2.40%9.18% 42 8.57 5.77 1.85 8.74 5.94 1.80 2.05% 2.84% −2.97% 43 16.98 11.844.24 15.48 12.16 4.26 −8.83% 2.70% 0.52% 44 9.23 7.54 1.75 9.27 7.641.80 0.47% 1.27% 2.69% 45 30.14 26.91 10.80 33.36 28.82 10.31 10.68%7.10% −4.56% 46 8.40 6.62 2.89 8.09 6.66 3.03 −3.75% 0.56% 4.84% 4718.84 14.09 3.83 18.55 14.25 3.96 −1.54% 1.14% 3.37% 48 9.96 7.62 2.319.84 7.50 2.25 −1.19% −1.56% −2.47% 49 11.93 8.98 3.37 18.55 14.39 4.0155.49% 60.19% 19.16% 50 4.37 3.57 1.61 4.25 3.10 1.39 −2.70% −13.15%−13.15% Average 9.25 7.31 2.63 9.36 7.49 2.59 0.71% 1.68% −0.71% PHYSIO-51 20.98 11.65 5.954 20.12 11.33 5.238 −4.10% −2.76% −12.03% LOGICAL 5224.85 20.61 8.71 24.85 20.44 5.85 0.00% −0.82% −32.79% FEET 53 8.73 4.821.93 8.37 4.68 1.88 −4.15% −2.92% −2.60% 54 8.66 6.93 1.80 8.46 6.421.56 −2.40% −7.44% −13.64% 55 13.53 11.08 3.60 13.82 11.49 4.31 2.14%3.65% 19.94% 56 28.02 22.69 9.07 27.93 22.40 9.30 −0.32% −1.28% 2.50% 578.56 7.13 2.32 7.19 5.62 2.01 −16.04% −21.19% −13.45% 58 7.99 6.06 2.577.67 5.52 2.22 −4.03% −8.92% −13.60% 59 9.51 7.20 2.89 8.64 6.81 2.71−9.12% −5.47% −6.19% 60 8.54 6.75 2.89 8.47 6.47 2.89 −0.73% −4.16%−0.03% 61 10.15 7.56 3.35 10.26 7.41 3.10 1.14% −1.96% −7.66% 62 7.425.46 2.11 7.62 5.96 2.18 2.80% 9.03% 3.61% 63 7.04 5.94 2.51 6.16 5.171.99 −12.49% −13.00% −20.82% 64 17.59 10.21 4.04 17.77 10.79 4.10 1.02%5.77% 1.41% 65 6.93 5.16 1.43 9.36 7.81 2.49 34.99% 51.27% 74.70% 666.03 4.96 2.01 6.08 4.92 1.79 0.78% −0.93% −11.12% 67 15.50 9.45 4.3414.38 8.91 4.27 −7.23% −5.67% −1.66% 68 6.80 5.73 1.92 6.60 5.64 1.93−2.88% −1.48% 0.57% 69 12.41 10.34 3.25 12.12 10.07 3.12 −2.34% −2.61%−4.00% 70 14.25 11.82 3.25 13.77 11.20 3.11 −3.37% −5.21% −4.25% 71 3.813.05 1.07 4.28 3.27 1.32 12.12% 7.18% 22.67% 72 5.42 4.30 1.50 4.92 3.951.36 −9.28% −8.21% −8.90% 73 43.94 39.72 16.43 37.19 31.05 16.01 −15.36%−21.83% −2.56% 74 7.24 6.04 2.01 7.96 6.08 1.82 10.02% 0.53% −9.39% 7515.57 12.25 4.08 15.40 12.03 4.10 −1.09% −1.80% 0.42% Average 12.78 9.883.80 12.38 9.42 3.63 −7.23% −5.67% −1.66% AVERAGE 11.12 8.55 3.23 11.098.49 3.16 1.55% 1.58% 0.44%

indicates data missing or illegible when filed

Table 2 below corresponds to the test with an insole according to theinvention: The subjects are the same as for Table 1. Subjects 1 to 25have flat feet, subjects 26 to 50 have hollow feet, and subjects 51 to75 have physiological feet.

TABLE 2 INSOLE ACCORDING TO THE INVENTION Morning Evening EvolutionEvolution Evolution Type of Subject PV TAPV TAMV PV TAPV TAMV of PV ofTAPV of TAMV feet No. (cm/s) (cm/s) (cm/s) (cm/s) (cm/s) (cm/s) (%) (%)(%) FLAT 1 3.99 3.22 1.25 5.96 4.28 2.00 49.35% 32.70% 60.47% FEET 217.64 10.48 4.03 22.49 16.63 7.38 27.49% 58.68% 83.18% 3 10.73 5.52 1.7812.25 6.26 1.90 14.17% 13.33% 7.09% 4 5.42 4.31 2.06 11.51 8.33 3.43112.11% 93.18% 66.28% 5 3.88 2.73 0.95 5.85 3.81 1.30 50.94% 39.71%36.59% 6 15.71 12.57 4.91 15.80 9.72 4.11 0.57% −22.69% −16.46% 7 7.816.00 2.31 12.37 8.47 3.15 58.33% 41.04% 36.35% 8 3.86 3.09 1.03 5.453.77 1.38 41.07% 22.18% 33.87% 9 5.72 4.90 2.24 10.03 7.86 3.39 75.16%60.51% 51.50% 10 10.35 8.84 1.62 15.08 12.95 2.73 45.76% 46.54% 68.68%11 18.18 15.19 6.32 25.70 21.44 8.96 41.36% 41.15% 41.76% 12 9.06 6.553.18 15.46 9.61 4.72 70.62% 46.72% 48.30% 13 5.26 4.23 1.65 8.03 6.311.89 52.59% 49.17% 14.94% 14 10.40 8.23 3.32 15.10 11.90 5.19 45.16%44.66% 56.43% 15 17.60 12.37 5.49 29.20 21.14 10.12 65.91% 70.90% 84.51%16 12.26 7.54 3.91 18.63 14.49 5.83 51.96% 92.25% 48.98% 17 19.48 16.316.00 23.83 17.38 7.72 22.33% 6.56% 28.69% 18 9.63 7.67 1.94 11.87 9.642.83 23.26% 25.61% 46.15% 19 5.17 4.23 1.47 11.56 8.78 2.32 123.51%107.49% 57.72% 20 26.22 17.55 8.39 35.89 27.14 11.51 36.88% 54.64%37.15% 21 13.99 12.12 4.46 19.62 16.35 6.11 40.24% 34.90% 37.02% 2211.89 10.19 3.66 15.96 12.26 3.94 34.23% 20.36% 7.63% 23 6.85 5.23 1.9719.29 16.05 5.10 181.73% 207.18% 158.95% 24 11.38 8.09 1.89 16.56 11.793.86 45.52% 45.81% 104.67% 25 16.65 9.73 5.06 31.40 18.48 8.91 88.59%90.01% 75.85% Average 11.17 8.27 3.23 16.60 12.19 4.79 55.95% 52.90%51.05% HOLLOW 26 7.05 6.03 2.02 10.55 8.93 3.03 49.67% 48.21% 50.22%FEET 27 5.39 3.94 1.75 8.39 5.46 1.78 55.68% 38.43% 1.25% 28 3.78 3.011.33 5.28 3.81 1.34 39.79% 26.56% 0.75% 29 10.78 8.68 3.45 16.43 13.775.67 52.41% 58.66% 64.31% 30 5.28 3.31 1.46 6.77 3.65 1.31 28.17% 10.28%−10.13% 31 5.07 4.07 1.52 6.06 4.61 1.65 19.33% 13.31% 8.22% 32 5.634.66 1.77 7.50 6.16 2.28 33.29% 32.23% 28.57% 33 10.10 8.47 3.02 13.0211.22 4.06 28.96% 32.45% 34.55% 34 12.39 10.87 4.21 17.36 14.31 5.8940.11% 31.65% 39.77% 35 4.44 3.42 1.18 5.54 4.21 1.33 24.77% 23.25%12.28% 36 3.86 2.61 0.93 5.13 3.40 0.96 32.92% 30.20% 3.27% 37 5.69 3.941.35 8.56 5.79 2.25 50.50% 46.89% 66.86% 38 8.01 5.59 1.74 11.95 8.492.15 49.11% 51.95% 23.72% 39 10.05 7.75 2.60 13.15 9.98 3.32 30.83%28.82% 27.63% 40 6.09 4.83 1.58 9.42 7.57 2.45 54.58% 56.90% 54.71% 418.71 7.44 1.92 11.61 9.59 2.93 33.30% 28.82% 52.71% 42 8.45 6.37 1.7313.75 9.81 2.73 62.82% 53.95% 57.93% 43 16.09 12.28 3.69 23.87 18.477.02 48.35% 50.41% 90.34% 44 9.36 7.47 1.78 15.12 12.50 2.51 61.61%67.38% 41.06% 45 30.68 26.33 10.35 39.79 34.98 12.41 29.69% 32.85%19.91% 46 8.51 6.80 3.11 13.34 11.21 4.43 56.83% 64.95% 42.61% 47 18.6114.22 3.92 30.59 23.77 8.53 64.37% 67.16% 117.71% 48 10.15 7.46 2.2614.50 11.81 3.44 42.84% 58.35% 52.42% 49 11.87 9.04 3.38 26.05 21.697.93 119.46% 140.07% 134.98% 50 4.43 3.52 1.57 5.08 3.82 1.74 14.68%8.40% 10.56% Average 9.22 7.28 2.54 13.55 10.76 3.72 44.96% 44.09%41.05% PHYSIO- 51 21.21 12.84 6.45 30.6 16.13 7.736 44.27% 25.62% 19.98%LOGICAL 52 24.88 20.60 8.59 38.49 31.34 12.80 54.70% 52.14% 49.10% FEET53 8.413 4.79 1.89 12.02 8.341 1.89 42.87% 73.99% 0.00% 54 8.82 7.031.94 13.77 10.73 2.99 56.16% 52.55% 54.60% 55 13.50 11.04 3.56 19.8816.22 5.19 47.26% 46.92% 45.63% 56 28.00 22.40 10.14 42.21 34.50 15.2550.75% 54.02% 50.34% 57 8.57 7.25 2.34 10.44 8.76 2.93 21.71% 20.73%25.09% 58 8.01 5.83 2.55 8.71 6.66 3.04 8.72% 14.40% 19.34% 59 9.18 7.192.85 14.62 10.99 4.34 59.26% 52.91% 52.14% 60 8.43 6.41 2.88 13.57 11.483.99 60.95% 79.01% 38.55% 61 10.15 7.51 2.47 18.99 14.18 5.98 87.19%88.94% 141.69% 62 7.58 5.51 2.23 11.42 9.32 3.30 50.64% 69.19% 48.18% 637.05 5.77 2.57 9.91 8.71 3.79 40.68% 50.85% 47.72% 64 17.58 10.16 3.4025.38 15.84 5.50 44.37% 55.98% 61.71% 65 9.18 7.82 2.94 15.35 13.26 4.5867.17% 69.67% 56.01% 66 5.99 5.09 2.05 11.67 10.10 2.79 94.89% 98.49%36.11% 67 15.68 9.50 4.66 22.60 13.18 6.00 44.13% 38.72% 28.78% 68 6.835.73 1.96 9.77 7.66 2.41 42.95% 33.58% 23.23% 69 12.40 10.33 1.95 17.7614.87 4.68 43.23% 43.91% 140.58% 70 14.32 11.63 3.17 19.50 15.02 4.8036.17% 29.15% 51.42% 71 3.87 3.29 1.14 6.44 5.14 1.95 66.26% 56.51%70.84% 72 5.43 4.28 1.47 5.96 4.27 1.50 9.82% −0.12% 2.18% 73 44.4040.23 16.02 52.92 46.76 16.90 19.19% 16.23% 5.49% 74 7.22 5.92 1.9612.99 11.04 3.54 79.89% 86.49% 80.79% 75 15.66 12.34 4.19 22.96 18.178.02 46.62% 47.30% 91.61% Average 12.89 10.02 3.81 18.72 14.51 5.4448.79% 50.29% 49.64% AVERAGE 11.09 8.53 3.20 16.29 12.49 4.65 49.90%49.09% 47.25%

Thus, regardless of the type of foot analyzed(hollow/flat/physiological), the study demonstrates an improvement inhemodynamics obtained by wearing an insole (1) according to theinvention.

1. A molded insole, comprising a base, an internal lateral arch that isprovided to accommodate the arch of the foot and that is raised relativeto the base, and at least one hard region that is integrated into thebase, having a hardness equal to or greater than that of the base,characterized in that the base and the internal lateral arch of theinsole constitute a single, mono-material part
 2. The insole accordingto claim 1, characterized in that the internal lateral arch has a volumeadapted to the volume of the arch of the patient's foot, in particularin the case of dysmorphism.
 3. The insole according to claim 1,characterized in that the internal lateral arch has a volume and aposition determined according to three parameters: patient gender;patient shoe size; and patient foot morphology.
 4. The insole accordingto claim 3, characterized in that the patient foot morphology parameterhas three possibilities: flat, hollow, or physiological foot.
 5. Theinsole according to claim 4, characterized in that a maximum thicknessof the insole is 5.6±0.2 mm for a flat foot, 8.4±0.4 mm for a hollowfoot, and 8.8±0.2 mm for physiological foot.
 6. The insole according toclaim 1, characterized in that the internal lateral arch has a curvedlower surface forming a hollow with respect to a lower plane of the baseand a curved upper surface projecting from an upper plane of the base.7. The insole according to claim 6, characterized in that the internallateral arch has lower and upper surfaces, the lower surface having agreater slope than the upper surface.
 8. The insole according to claim6, having an upper surface that is smooth.
 9. The insole according toclaim 1, characterized in that the hard regions are integrated intohollow chambers formed in the thickness of the base, said hard regionsopening onto an underside of said base.
 10. The insole according toclaim 1, comprising an upper layer covering the mono-material part. 11.The insole according to claim 10, characterized in that: the insole, inthe parts of the base without hard regions, measured on the upper sideand over its entire thickness, has a hardness between 30 and 56 on theShore A scale depending on the thickness, and the insole, in the partsof the base incorporating hard regions, measured on the upper side andover its entire thickness, has a hardness between 65 and 77 on the ShoreA scale depending on the thickness.
 12. A footwear item, comprising aninsole according to claim
 1. 13. A manufacturing method of an insoleaccording to claim 1, comprising the following steps: a) a step offorming at least one hard region having a hardness equal to or greaterthan that of the base; b) a step of cutting from a mono-material strip,with or without an upper layer laminated on its surface, a preform tothe dimensions of the mold corresponding to the insole; c) a step ofmolding the preform in one part comprising the base and the internallateral arch, formed projecting from the base, at the insole desiredsize; d) a step of assembling the part, including the base and theinternal lateral arch once removed from the mold, and the hard regions;and e) a finishing step to obtain the insole.
 14. A method according toclaim 13, characterized in that step c) of molding the preform iscarried out by compressing in a mold a mono-material part of constantthickness, hardness and density, the mold having shapes intended toconfigure the base so that its upper surface does not undergodeformations when in contact with hard regions.
 15. The method accordingto claim 13, characterized in that step b) comprises, as a preliminarystep, laminating a strip corresponding to the upper layer over theentire surface of the mono-material strip.